AN2 Therapeutics Announces Epetraborole Granted Orphan Drug Designation in the U.S. for the Treatment of Infections Caused by Non-Tuberculous Mycobacteria
Menlo Park, CA – February 16, 2022 – AN2 Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to epetraborole for the treatment of infections caused by non-tuberculous mycobacteria (NTM). AN2 Therapeutics is developing epetraborole as a once-daily, orally administered treatment for patients with NTM lung disease, with an initial focus on treatment-refractory Mycobacterium avium complex (MAC) lung disease.
“Obtaining orphan status is a key milestone within our development strategy for epetraborole,” said Eric Easom, President and Chief Executive Officer of AN2 Therapeutics. “We believe epetraborole has the potential to significantly improve upon the existing standard of care and we look forward to advancing our development program to meet the needs of this underserved patient population.”
The FDA grants orphan drug designation to medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. The designation provides certain incentives, which includes seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits, and waiver of certain FDA fees. The FDA has also granted Qualified Infectious Disease Product and Fast Track designations for epetraborole in treatment-refractory MAC lung disease.
About AN2 Therapeutics, Inc.
AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. AN2 is developing epetraborole, a once-daily oral treatment for patients with NTM lung disease, a rare, chronic and progressive infectious disease caused by bacteria known as mycobacteria that leads to irreversible lung damage and can be fatal. For more information, visit www.an2therapeutics.com.
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